The goal of this phase I clinical trial is to evaluate the usefulness of an imaging test (zirconium Zr89 panitumumab \[89Zr panitumumab\]) with positron emission tomography (PET)/computed tomography (CT) for diagnosing the spread of disease from where it first started (primary site) to other places in the body (metastasis) in patients with head and neck squamous cell carcinoma. Traditional PET/CT has a low positive predictive value for diagnosing metastatic disease in head and neck cancer. 89Zr panitumumab is an investigational imaging agent that contains radiolabeled anti-EGFR antibody which is overexpressed in head and neck cancer. The main question this study aims to answer is the sensitivity and specificity of 89Zr panitumumab for the detection of indeterminate metastatic lesions in head and neck cancer.
Participants will receive 89Zr panitumumab infusion and undergo 89Zr panitumumab PET/CT 1 to 5 days after infusion. Participants will otherwise receive standard of care evaluation and treatment for their indeterminate lesions.
Researchers will compare the 89Zr panitumumab to standard of care imaging modalities (magnetic resonance imaging (MRI), CT, and/or PET/CT).
Age >= 19 years
Biopsy confirmed diagnosis of squamous cell carcinoma of the head and neck
Subjects diagnosed with any T stage, any subsite within the head and neck. Subjects with recurrent disease or a new primary will be allowed
Must have evidence of indeterminate metastatic squamous cell carcinoma (SCC) based on 18F-fluorodeoxyglucose (FDG)-PET/CT or Primary SCC with suspicious Lymph Nodes on CT prior to surgical removal
Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment
History of infusion reactions to other monoclonal antibody therapies
Pregnant (based on screening serum pregnancy test and day 0 urine pregnancy test administered before unlabeled panitumumab), or breastfeeding
Magnesium or potassium lower than the normal institutional values
Single group
Panitumumab
Biological/VaccineGiven IV
Zirconium Zr 89 Panitumumab
DrugGiven IV
Positron Emission Tomography
Procedure/SurgeryUndergo PET/CT
Computed Tomography
Procedure/SurgeryUndergo PET/CT
Electronic Health Record Review
Other interventionAncillary studies
Sensitivity of zirconium Zr 89 panitumumab (89Zr-panitumumab
The total number of head and neck squamous cell carcinoma lesions accurately detected by 89Zr-panitumumab using positron emission tomography (PET)/computed tomography (CT) imaging (test) will be compared with lesions identified as positive during the 36 +/- 6 month follow-up period (gold standard). Significance will be assessed at an alpha level of 0.05 and, to assess uncertainty, 95% confidence intervals will be provided for all estimates.
Specificity of 89Zr-panitumumab
The total number of head and neck squamous cell carcinoma lesions accurately detected by 89Zr-panitumumab using PET/CT imaging (test) will be compared with lesions identified as positive during the 36 +/- 6 month follow-up period (gold standard). Significance will be assessed at an alpha level of 0.05 and, to assess uncertainty, 95% confidence intervals will be provided for all estimates.
Sensitivity of 89Zr-panitumumab
The sensitivity of 89Zr-panitumumab will be compared to the sensitivity of standard of care imaging modalities, including magnetic resonance imaging (MRI), CT, and/or fludeoxyglucose F-18 (18F-FDG) PET/CT. Will use the matched pair Durkalski's test, accounting for the cluster-correlation within subjects, for the sensitivity comparisons.
Specificity of 89Zr-panitumumab
The specificity of 89Zr-panitumumab will be compared to the specificity of standard of care imaging modalities, including MRI, CT, and/or 18F-FDG PET/CT. Will use the matched pair Durkalski's test, accounting for the cluster-correlation within subjects, for the specificity comparisons.
Click on the lead sponsor to view all of their trials.
Eben Rosenthal
Lead sponsor
Vanderbilt-Ingram Cancer Center
Sponsor institution
Vanderbilt-Ingram Cancer Center
Collaborator
Vanderbilt University Medical Center
Collaborator
